[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Rules and Regulations]
[Pages 9244-9245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Monensin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
provides for minor revisions to labeling of monensin Type A medicated 
articles for chickens. FDA is also amending the regulations to simplify 
the organization of special labeling requirements for formulations 
(Type A medicated articles, Type B and Type C medicated feeds) 
containing monensin for poultry and game birds. This action is being 
taken to improve the clarity of the regulations.

DATES: This rule is effective March 1, 2007.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 38-878 that provides for use of COBAN 60 and COBAN 
90 (monensin, USP) Type A medicated articles in feed of chickens. The 
supplement provides for minor revisions to labeling. The supplemental 
NADA is approved as of February 7, 2007, and the regulations in 21 CFR 
558.355 are amended to reflect the approval.
    In addition, FDA is taking this opportunity to amend the 
regulations to simplify the organization of special labeling 
requirements for formulations (Type A medicated articles, Type B and 
Type C medicated feeds) containing monensin for poultry and game birds. 
Similar restructuring was done recently for monensin formulations used 
in ruminants (71 FR 66231, November 14, 2006). This action is being 
taken to improve the clarity of the regulations.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


0
2. In Sec.  558.355, revise paragraphs (a), (b)(1), (b)(4), (b)(6), 
(d)(4), (d)(5), and (d)(8); and add paragraphs (d)(9)(iv) through 
(d)(9)(vi), and (d)(10)(iv) through (d)(10)(vi) to read as follows:


Sec.  558.355  Monensin.

    (a) Specifications. Type A medicated articles containing monensin, 
USP.
    (b) * * *
    (1) To No. 000986: 36.3 (for export only), 44, 45, 60, or 90.7 
grams per pound for use as in paragraphs (f)(1)(i) and (f)(4) of this 
section.
* * * * *
    (4) To No. 000986: 45, 60, or 90.7 grams per pound for use as in 
paragraph (f)(2) of this section.
* * * * *
    (6) To No. 000986: 45, 60, or 90.7 grams per pound for use as in 
paragraph (f)(5) of this section.
* * * * *
    (d) * * *
    (4) Liquid Type B feeds shall bear an expiration date of 8 weeks 
after its date of manufacture.
    (5) All Type A medicated articles containing monensin shall bear 
the following warning statement: When mixing and handling monensin Type 
A medicated articles, use protective clothing, impervious gloves, and a 
dust mask. Operators should wash thoroughly with soap and water after 
handling. If accidental eye contact occurs, immediately rinse 
thoroughly with water.
* * * * *
    (8) Type A medicated articles containing monensin intended for use 
in chickens, turkeys, and quail shall bear the following statements:
    (i) Do not allow horses, other equines, mature turkeys, or guinea 
fowl access to feed containing monensin. Ingestion of monensin by 
horses and guinea fowl has been fatal.
    (ii) Must be thoroughly mixed in feeds before use.
    (iii) Do not feed undiluted.
    (iv) Do not feed to laying chickens.
    (v) Do not feed to chickens over 16 weeks of age.
    (vi) For replacement chickens intended for use as cage layers only.
    (vii) Some strains of turkey coccidia may be monensin tolerant or 
resistant. Monensin may interfere with development of immunity to 
turkey coccidiosis.

[[Page 9245]]

    (viii) In the absence of coccidiosis in broiler chickens the use of 
monensin with no withdrawal period may limit feed intake resulting in 
reduced weight gain.
    (9) * * *
    (iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and 
(d)(8)(viii) of this section.
    (v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and 
(d)(8)(vii) of this section.
    (vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) 
of this section.
    (10) * * *
    (iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), 
(d)(8)(vi), and (d)(8)(viii) of this section.
    (v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this 
section.
    (vi) Quail: See paragraph (d)(8)(i) of this section.
* * * * *

    Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-3621 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S